Loratadine Allergy Relief
- Product NDC
- 51660-526
- 11-digit product format
- 516600526
- Labeler code
- 51660
- Product ID
- 51660-526_ab379305-5823-49e9-89ca-641c1d37a6f3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- OHM LABORATORIES INC.
- Application
- ANDA076134
- Marketing category
- ANDA
- Marketing start
- 2017-11-01
- Substance
- LORATADINE
- Active strength
- 10 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| unfinished product | product | 51660-526 | UNFINISHED | Active or certified unfinished drug listing | 2026-10-12 | ||
| unfinished package | package | 51660-526 | 51660-526-03 | UNFINISHED | Active or certified unfinished drug listing | 2026-10-12 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished product | product | a6255e0c9aa5… | a0211a219f2e… | |
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished package | package | 51660-526-03 | a6255e0c9aa5… | a0211a219f2e… |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished product | product | 390b4c401c3f… | 2c692c2daee3… | |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished package | package | 51660-526-03 | 390b4c401c3f… | 2c692c2daee3… |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished product | product | e30019b0c005… | a3f0b14938b7… | |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished package | package | 51660-526-03 | e30019b0c005… | a3f0b14938b7… |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished product | product | bbbc9f937eca… | 946b9c97cf81… | |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished package | package | 51660-526-03 | bbbc9f937eca… | 946b9c97cf81… |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished product | product | f268b84574a6… | 26285f5ac5df… | |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished package | package | 51660-526-03 | f268b84574a6… | 26285f5ac5df… |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished product | product | f764e8902f78… | 92046438deef… | |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished package | package | 51660-526-03 | f764e8902f78… | 92046438deef… |
| 2025-01-20 13:05 UTC · source 2025-01-17 | unfinished product | product | 68b1e3bced9e… | 98a755eb8bc6… | |
| 2025-01-20 13:05 UTC · source 2025-01-17 | unfinished package | package | 51660-526-03 | 68b1e3bced9e… | 98a755eb8bc6… |
| 2024-11-29 20:42 UTC · source 2024-11-29 | unfinished product | product | 05c55d027831… | ca05dca9dc4c… | |
| 2024-11-29 20:42 UTC · source 2024-11-29 | unfinished package | package | 51660-526-03 | 05c55d027831… | ca05dca9dc4c… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076134-001 | LORATADINE | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | f41ea6bd6efb… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Loratadine Allergy Relief
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LORATADINE | 10 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 7AJO3BO7QN | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 311372 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| c35f2cc1-f76d-4824-b0a5-747bca0c3b85 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51660-526-01 | Loratadine Allergy Relief | 100 in 1 BOTTLE | TABLET | 100 | 10 | |
| 51660-526-05 | Loratadine Allergy Relief | 500 in 1 BOTTLE | TABLET | 500 | 10 | |
| 51660-526-11 | Loratadine Allergy Relief | 10 in 1 BLISTER PACK | TABLET | 10 | 10 | |
| 51660-526-30 | Loratadine Allergy Relief | 30 in 1 BOTTLE | TABLET | 30 | 10 | |
| 51660-526-31 | Loratadine Allergy Relief | 30 in 1 BLISTER PACK | TABLET | 30 | 10 | |
| 51660-526-53 | Loratadine Allergy Relief | 300 in 1 BOTTLE | TABLET | 300 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 51660-526-01 | EA - Each | 51660-526 | 23ef566a-7fbc-42f3-aa01-eac9d9a2b120 | 1 | 2012-07-24 |
| 51660-526-05 | EA - Each | 51660-526 | 82cd5b39-27fb-4a5f-8caa-efa85266448a | 1 | 2012-07-24 |
| 51660-526-30 | EA - Each | 51660-526 | bd00fc2c-7bf3-47f5-a7cd-7aeaec6fdddb | 1 | 2019-10-07 |
| 51660-526-31 | EA - Each | 51660-526 | 2d65982b-8238-4b58-a5c6-9732389e4607 | 1 | 2012-07-24 |
| 51660-526-53 | EA - Each | 51660-526 | 16eb7af6-5422-4617-aafa-52f14555717f | 1 | 2018-09-05 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Loratadine | LORATADINE | Chain Drug Marketing Association Inc. | b4edf5b1-398d-405a-8a42-76044b31ebb7 | 2018-08-27 | Warnings | 076134 ANDA076134 |
| Loratadine Allergy Relief | LORATADINE | HEB | 6703e4f3-e9b8-4c70-9085-3d6ac0d7fbda | 2018-05-14 | Warnings | 076134 ANDA076134 |
| Loratadine | LORATADINE | Premier Value | 778a6979-ea47-4381-8c40-84b3c2325a7e | 2018-01-11 | Warnings | 076134 ANDA076134 |
| Loratadine Allergy Relief | LORATADINE | LIDL US, LLC | 11bc027c-d28d-45f0-a4cb-24a3834a6995 | 2018-01-09 | Warnings | 076134 ANDA076134 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 51660-526-01 | 51660052601 | 100 TABLET in 1 BOTTLE (51660-526-01) | 100 tablet | 2017-11-01 | 0000-00-00 | No | No | Current |
| 51660-526-03 | 51660052603 | 5000 TABLET in 1 BAG (51660-526-03) | 5000 tablet | 28-NOV-24 | Current | |||
| 51660-526-05 | 51660052605 | 500 TABLET in 1 BOTTLE (51660-526-05) | 500 tablet | 2017-11-01 | 0000-00-00 | No | No | Current |
| 51660-526-11 | 51660052611 | 10 TABLET in 1 BLISTER PACK (51660-526-11) | 10 tablet | 2017-11-01 | No | No | Current | |
| 51660-526-30 | 51660052630 | 30 TABLET in 1 BOTTLE (51660-526-30) | 30 tablet | 2019-02-01 | 0000-00-00 | No | No | Current |
| 51660-526-31 | 51660052631 | 30 TABLET in 1 BLISTER PACK (51660-526-31) | 30 tablet | 2017-11-01 | 0000-00-00 | No | No | Current |
| 51660-526-53 | 51660052653 | 300 TABLET in 1 BOTTLE (51660-526-53) | 300 tablet | 2017-11-01 | 0000-00-00 | No | No | Current |